# K112910: AP 72OS Semi-Automated Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Dec 20, 2012 after 444 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AP 72OSTM Semi-Automated Instrument is a semi-automated processor for use with the OPTIGENO Assay. The OPTIGEN® Assay is an in vitro diagnostic test for use in the semi-quantitative determination of circulating allergen-specific IgE concentrations in human serum. It is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The device is designed for use in clinical laboratories.

Source page: https://510kreport.com/device/K112910
Methodology: https://510kreport.com/methodology